Qilu Pharmaceutical's Class 1 Biologic QLS31906 Granted IND Approval to Target Multi-Billion-Yuan Oncology Market

On February 18, the CDE official website showed that Qilu Pharmaceutical's Class 1 biologic drug, Injectable QLS31906, received implied permission for clinical trials, intended for the treatment of malignant tumors. Injectable QLS31906 is Qilu Pharmaceutical’s first Class 1 new drug approved for clinical trials this year. The company currently has 24 Class 1 new drugs in its R&D pipeline at the stage of clinical application or above.

Class 1 biologic drug QLS31906 for injection is intended for the treatment of malignant tumors. The field of oncology has become a regular focus of Qilu Pharmaceutical's innovative research and development.

Not long after taking over in 2022, Qilu Pharmaceutical has already submitted three Class 1 biological drugs for clinical trials, including QL1706 Injection, QLS21908 for Injection, and QL1604 Injection, with QLS21908 for Injection being the first submission for clinical trials. In terms of clinical trials, QLS31906 for Injection is the first Class 1 new drug approved for clinical trials by Qilu Pharmaceutical this year.

Data from Menet shows that in recent years, the domestic anti-tumor drug market in China has continued to expand. In 2020, the sales of anti-tumor drugs at terminals of urban public hospitals, county-level public hospitals, urban community health centers, and township health centers in China (referred to as Chinese public medical institutions) exceeded 100 billion yuan, with a year-on-year increase of 10.69%. In the first half of 2021, sales surpassed 57 billion yuan, with a year-on-year increase of 17.74%.

Sales of Anti-Tumor Chemical Drugs in Chinese Public Medical Institutions (Unit: Ten Thousand Yuan)

Source: Terminal Competition Pattern of Public Medical Institutions in China, MiNe Network

In recent years, Qilu Pharmaceutical has adhered to an innovation-driven strategy and continuously increased its investment in scientific research. Currently, Qilu Pharmaceutical has 24 Class 1 new drugs in its R&D pipeline at the clinical application stage or above, including 18 large-molecule biologics involving monoclonal antibodies, bispecific antibodies, and ADCs. The company's first Class 1 new drug, ALK/ROS1 inhibitor IruOc tablets, submitted an NDA in July 2021 and is expected to be approved for marketing this year.